UMIN-CTR Clinical Trial

Public title

Single-dose-administration study of GT-02037 subcutaneous injection in healthy Japanese male subjects

Acronym

GT-02037 single dose study

Scientific Title

Single-dose-administration study of GT-02037 subcutaneous injection in healthy Japanese male subjects

Scientific Title:Acronym

GT-02037 single dose study

Region

Japan

Condition

Acromegaly

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Primary objective
Investigation for safety of GT-02037 in male healthy adult subjects.
Secondary objective
Investigation for pharmacokinetics of GT-02037.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Safety of GT863
Physical examination (The day prior to administration (Day-1), Pre, 1*, 4, 24, 48hours, Follow up (Day7) )
Injection site reaction (Pre, 1*, 4, 24, 48hours, Day7)
Vital sign (Day-1, Pre, 1*, 4, 24, 48hours, Day7)
Electrocardiogram (Day-1, 1*, 4, 24hours, Day7)
SpO2 (Pre, 15minutes)
Laboratory examination (Day-1, 24hours, Day7)
Adverse event
* Only Step 1

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

GT-02037 (0.1, 0.5, 1.0, 2.0mg) single dose

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

40

years-old

>=

Gender

Male

Key inclusion criteria

(1) Japanese male healthy adult subjects
(2) between 20 and 40 years old
(3) Body weight over 50 kg
(4) BMI over 18.5 under 25.0 kg/m2
(5) Having given written informed consent prior to any procedure related to the study

Key exclusion criteria

(1) Any subject who have present and/or past history of disease of heart and circulatory system, liver, kidney, digestive system, and blood system, central nerves system, respiratory system.
(2) Hypersensitivity or Idiosyncratic to drugs
(3) History of allergy to any clinically important allergy
(4) A constitution prone to hypersensitivity reaction such as rash (erythema, wheal, etc)
(5) Any subject have present and/or past history of drug and alcohol addiction.
(6) Positive serologic findings for treponema pallidum (syphilis), human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg),and/or hepatitis C virus (HCV) antibodies.
(7) Positive findings of urine drug screen.
(8) Any drug history within 2weeks before study day 1.
(9) Use of any investigational drug within 16weeks before study day 1.
(10) Donation of blood over 400mL within 14 weeks, 200mL within 4weeks before study day 1. Blood compornent donation within 2weeks.
(11) Any subject not able to agree to make contraception during the study.
(12) A past medical history of somatostatin analog administration
(13) Any clinically important deviation from normal limits in physical examination, vital signs, 12-lead electrocardiograms (ECGs), or clinical laboratory test results.
(14) Subjects deemed by the investigator to be inappropriate according for inclusion in the study.

Target sample size

24

Name of lead principal investigator

1st name
Middle name
Last name	Setsuo Hasegawa

Organization

Pharmaspur Inc.

Division name

Internal medicine

Zip code

Address

1-2-10 Nihonbashi. Chuo-ku, Tokyo, Japan

TEL

03-6214-2670

Email

setsuo_hasegawa@pharmaspur.com

Name of contact person

1st name
Middle name
Last name	Ayaka Kiyota

Organization

Pharmaspur Inc.

Division name

Clinical study

Zip code

Address

1-2-10 Nihonbashi. Chuo-ku, Tokyo, Japan

TEL

03-6214-2670

Homepage URL

Email

ayaka_kiyota@pharmaspur.com

Institute

Pharmaspur Inc.

Institute

Department

Personal name

Organization

Gly Tech, Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

07

Month

20

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2017

Year

07

Month

10

Day

Date of IRB

Anticipated trial start date

2017

Year

07

Month

21

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

07

Month

20

Day

Last modified on

2017

Year

11

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032128